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Completed

NCT Number: NCT00689676

Expressive Language and Cognitive Early Development in Very Low Birth-Weight Preterm Toddlers

The aim of the present study is to describe the performance of very low birth-weight preterm toddlers regarding expressive language and cognitive development during sensorimotor and beginning of pre-operational periods, as well as to compare the performance presented by these children to that presented by their full-term peers, according to Genetic Epistemology theoretical principles.

The hypothesis of this study is that very-low birth weight preterms would present a poorer performance, concerning expressive language and cognition development,than their full-term peers.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 month–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University's Hospital

São Paulo, 05508-000, Brazil

About this study

Very low birth weight preterm infants are known to have risks of cognitive and behavioral problems, including learning difficulties, attention deficits and hyperactivity, as well as neuromotor deficits. Moreover, they are reported to have a high risk of speech and language impairments up to school age, even in cases where major neurological abnormalities are excluded. Impairments have been reported both in receptive and expressive language and, more specifically, in morphosyntax and naming.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Study Group:

Inclusion criteria

  • gestational age lower than 34 weeks (according to the date of last menstrual period - DLMP);
  • birth weight equal or lower than 1500g;
  • exposed only to Brazilian Portuguese

Exclusion criteria

  • presence of major malformations, genetic syndromes, severe neonatal asphyxia, hearing impairment or visual impairment.

Control Group:

Inclusion criteria

  • gestational age higher than 38 weeks;
  • adequate for gestational age;
  • birth weight higher than 2500g up to 3999g
  • exposed only to Brazilian Portuguese

Exclusion criteria

  • pre, peri or post natal intercurrence

Treatment and study plan

Primary outcomes

  1. Performance on monthly observations carried out after the initial evaluation

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 3, 2008
Registry last updated
Feb 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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